POS1402 COST-EFFECTIVENESS AND COST-UTILITY OF ADD-ON, LOW-DOSE PREDNISOLONE IN RA PATIENTS AGED 65+: THE PRAGMATIC, MULTICENTER, PLACEBO-CONTROLLED GLORIA TRIAL
Authors: L. Hartman, M. El Alili, M. Cutolo, D. Opris-Belinski, J. A. P. Da Silva, Z. Szekanecz, F. Buttgereit, P. Masaryk, R. Bos, M. R. Kok, S. Paolino, V. M. H. Coupé, W. Lems, M. Boers
Journal: Annals of the Rheumatic Diseases (2022)

Background Rheumatoid arthritis (RA) is a disease with substantial impact on quality of life, healthcare and societal costs [1]. Current treatment strategies, especially biologic drugs, result in high costs [2]. Previous studies have already found that a combination treatment strategy of disease-modifying antirheumatic drug(s) with initially medium-to-high doses of prednisolone resulted in better effects and lower costs compared to the treatment strategies without prednisolone [3, 4]. However, to our knowledge the cost-effectiveness of low-dose glucocorticoids (GCs), and that of GC overall in established RA has not been examined separately. Objectives To evaluate the cost-effectiveness and cost-utility of low-dose prednisolone in RA patients aged 65+. Methods The economic evaluation was performed as part of the placebo-controlled GLORIA trial of RA patients aged 65+ with a disease activity score in 28 joints (DAS28) ≥2.60. Eligible patients were randomized to 2 years 5 mg/day prednisolone or placebo. Patients were recruited from 28 clinical centers in seven European countries. All co-treatment, except for chronic oral GC, was allowed. The economic evaluation had a societal perspective with a time horizon of two years. Cost data were collected with questionnaires and from recorded events, and valued with unit prices of 2017. The primary effectiveness outcome was the DAS28. For cost-utility, quality-adjusted life years (QALYs) were estimated from the EuroQol-5 Dimension (EQ-5D) questionnaire. Standard regression models were used to estimate incremental costs and effects between the treatment groups. Bootstrapping assessed the uncertainty around the average differences in costs and health outcomes. Results In total, 444 of 451 randomized patients were included in the modified-intention-to-treat analysis (see main GLORIA study abstract). Patients were on average 72 years and had median 4 active comorbidities at baseline. Mean total costs over 2 years were k€10.8 in the prednisolone group, k€0.4 (95% CI –3.7; 1.9) lower than in the placebo group. Total direct medical costs were k€0.5 (95% CI –4.0; 1.5) lower in the prednisolone group. The mean number of QALYs was similar in both groups (difference 0.02 [–0.03; 0.06] in favor of prednisolone). The DAS28 was 0.38 lower in the prednisolone group than in the placebo group (0.19;0.56). The cost-effectiveness plane shows that the majority of the bootstrapped cost-effect pairs was situated in the southwest quadrant of the plane confirming the larger effects (i.e. decrease in DAS28) and non-significant lower costs in the prednisolone group (Figure 1). The cost-utility plane shows that the number of QALYs was similar for both groups and that the bootstrapped cost-utility pairs were slightly more located in the southeast quadrant confirming a very small increase in QALYs and slightly lower costs in the prednisolone group (Figure 1). Conclusion With greater effectiveness at non-significantly lower costs, low-dose, add-on prednisolone is cost-effective for RA compared to placebo over two years. QALYs were equal in both groups, most likely due to the impact of multiple comorbidities. References [1]Kobelt G. Elsevier. 2009;83-9. [2]Souliotis K et al. PLoS One. 2019;14:e0226287. [3]Ter Wee MM et al. RMD Open. 2017;3:e000502. [4]Verhoeven AC et al. Br J Rheumatol. 1998;37:1102-9. Acknowledgements The GLORIA project is funded by the European Union’s Horizon 2020 research and innovation programme under the topic ‘’Personalizing Health and Care’’, grant agreement No 634886. Disclosure of Interests Linda Hartman: None declared, Mohamed El Alili: None declared, Maurizio Cutolo: None declared, Daniela Opris-Belinski Speakers bureau: Abbvie, Pfizer, MSD, Novartis, Eli Lilly, Ewo Pharma, UCB, José Antonio P. da Silva: None declared, Zoltán Szekanecz: None declared, Frank Buttgereit Speakers bureau: Abbvie, AstraZeneca, Gruenenthal, Horizon Therapeutics, Mundipharma, Pfizer, Roche, Pavol MASARYK: None declared, Reinhard Bos: None declared, Marc R Kok: None declared, Sabrina Paolino: None declared, Veerle M. H. Coupé: None declared, WIllem Lems Speakers bureau: Pfizer, Galapagos, Lilly, Amgen, UCB, Maarten Boers Speakers bureau: BMS, Novartis, Pfizer